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The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Liberty University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Exercise, Neurotransmitters, Catecholimines, EEG

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • primary diagnosis of depression
  • 18-65 years of age
  • Physically fit to engage in physical exercise

Exclusion Criteria:

  • Participants with a history or current symptoms of psychosis
  • anticipation of psychiatric medication changes over the course of the study
  • Bipolar disorder or other disorder reflecting reality testing impairment.

Sites / Locations

  • Liberty University
  • Centra Health; Health Works

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Control group will serve as a wait list and not be exposed to the intervention.

The experimental group will engage in a mild-moderate level of structured and clinically supervised exercise program for approx. 30-45 mins 2-3 days per week for 12 weeks

Outcomes

Primary Outcome Measures

Scores on the Beck Depression Inventory-II
The BDI-II is a 21 item self-report screening tool that measures symptoms of depression.

Secondary Outcome Measures

Serum levels of serotonin and catecholomine
Blood collection pre and post intervention for the processing of serum for serotonin and catecholomine.

Full Information

First Posted
December 23, 2013
Last Updated
December 23, 2013
Sponsor
Liberty University
Collaborators
Centura Health
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1. Study Identification

Unique Protocol Identification Number
NCT02023281
Brief Title
The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers
Official Title
The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liberty University
Collaborators
Centura Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of exercise on the symptoms of depression using serum levels of serotonin, catecholamine's, Alpha EEG asymmetry, and self-report of symptoms as markers. In an attempt to further understand the mechanisms of improved mood through exercise; this study will examine the known factors that contribute to depressed mood in a single study using serotonin and catecholamine levels via blood serum and EEG slow wave asymmetry. Such information can be useful in understanding the overall neurological components of depression and the effects of exercise on the brain in depressed individuals that would make the prescription of exercise a viable treatment option.
Detailed Description
There is an increasing demand for clinical effective, safe, and cost conscious forms of treatment for depression. Research shows depression to account for the largest decrease in overall health compared to asthma, angina, arthritis, and diabetes (Maussavi, 2007). The cost of lost productivity at work due to depression is a new focus of research as no current and accurate numbers exist. Stewart, Ricci, Hahn, & Morganstein (2013) were among the first to examine this issue and found that lost productivity due to depression cost an estimated $44 billion dollars per year in spite of current medical treatments commonly prescribed. The lost productivity among those with depression and the low level of treatment suggest that there may be cost effective opportunities for improving depression outcomes within the general workforce and society at large. The question of value regarding the use of exercise as a treatment for depression has remained a source of investigation in recent years. In cooperation with Centra Health and Liberty University, this study seeks to understand the mechanisms that make exercise a viable treatment in depression by examining self-report of symptoms, serum levels of serotonin and catecholamines (epinephrine, norepinephrin, and dopamine) and frontal slow wave EEG activity as markers. Although these markers have been examined individually in previous studies, this is the only known study that examines each of these components in a single study. Such information can be useful in understanding the overall neurological components of depression and the effects of exercise on the brain in depressed individuals that would make the prescription of exercise a viable treatment in depression. Multiple trials, meta-analyses, and reviews have been conducted in the attempt to clarify the use of exercise in depressed patients. Research has shown that exercise as a treatment may result in fewer relapses than sertraline (Strohle, 2009). Similar results are indicated when exercise is prescribed as an adjunct treatment with psychotherapy (Balon, Sidhu, & Pankhuree, 2009; Blumenthal, Smith, & Hoffman, 2012; Gill, Womack, & Safranek, 2010). Preliminary characteristics of the ideal dosage of exercise as a treatment have been researched, although a definitive dose-response curve has yet to be produced (Callaghan, Khalil, Morres, & Carter, 2011; Perraton, Kumar, & Machotka, 2010). Electroencephalographic (EEG) scans have been shown to demonstrate a left frontal bias in alpha (8-12 Hz) and theta (4-7 Hz) wave activity (Allen, Urry, Hitt, & Coan, 2004; Demos, 2005; Iosifescu et al., 2008; Nissen et al., 2006). The up-training or down-training of individual bandwidths in the treatment of depression, anxiety, ADHD, and traumatic brain injury have long been established (La Vaque, 2002). Although there are no established norms for neurotransmitter levels, we know through clinical medication trials that the inhibition of the reuptake of serotonin and or norepinephrine improve mood. Previous studies examining low levels of serotonin and decreased mood have found a correlation between exercise and increased serotonin availability without the use of pharmaceuticals (Chaouloff et al., 1985; Ernst, Olsen, Pinel, Lam, & Christie, 2006; Jacobs & Fornal, 1999). More routine type studies often use neurotransmitter levels as markers (Lande, Williams, Fileta, 2012; Lidberg, Tuck, Asberg, Scalia-Tomba, & Bertilsson, 1985; Mann & Stanley, 1984).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Exercise, Neurotransmitters, Catecholimines, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group will serve as a wait list and not be exposed to the intervention.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will engage in a mild-moderate level of structured and clinically supervised exercise program for approx. 30-45 mins 2-3 days per week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
The experimental group will engage in mild-moderate level of exercise. This program will be structured and clinically supervised. Exercise will take place 2-3 days per week for a duration of 30-45 mins. for 12 weeks.
Primary Outcome Measure Information:
Title
Scores on the Beck Depression Inventory-II
Description
The BDI-II is a 21 item self-report screening tool that measures symptoms of depression.
Time Frame
Pre and post intervention over the 3 month span of the study
Secondary Outcome Measure Information:
Title
Serum levels of serotonin and catecholomine
Description
Blood collection pre and post intervention for the processing of serum for serotonin and catecholomine.
Time Frame
Pre and post intervention over the 3 month span of the study
Other Pre-specified Outcome Measures:
Title
Mean EEG alpha frequency data in the pre-frontal cortex.
Description
Participants will have an EEG measuring pre-frontal cortex mean alpha frequency.
Time Frame
Pre and post intervention over the 3 month span of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: primary diagnosis of depression 18-65 years of age Physically fit to engage in physical exercise Exclusion Criteria: Participants with a history or current symptoms of psychosis anticipation of psychiatric medication changes over the course of the study Bipolar disorder or other disorder reflecting reality testing impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy H Barclay, Ph.D.
Organizational Affiliation
Liberty University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liberty University
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Centra Health; Health Works
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24503
Country
United States

12. IPD Sharing Statement

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The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers

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